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About CSI

We are devoted to developing innovative solutions for treating peripheral and coronary artery disease, to help physicians conquer calcium, one of the largest challenges when treating PAD and CAD and help patients get back to what matters.

Read about our company policies, monitoring, public disclosures and other details.

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INDICATIONS & IMPORTANT SAFETY INFORMATION

DIAMONDBACK 360® Coronary Orbital Atherectomy System (OAS)
Indication: To facilitate stent delivery in patients with coronary artery disease who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.Contraindications: The OAS is contraindicated when the VIPERWIRE guide wire cannot pass across the coronary lesion or the target lesion is within a bypass graft or stent. The OAS is contraindicated when the patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy, or has angiographic evidence of thrombus, or has only one open vessel, or has angiographic evidence of significant dissection at the treatment site and for women who are pregnant or children.Warnings/Precautions: Performing treatment in excessively tortuous vessels or bifurcations may result in vessel damage; The OAS was only evaluated in severely calcified lesions; A temporary pacing lead may be necessary when treating lesions in the right coronary and circumflex arteries; On-site surgical back-up should be included as a clinical consideration; Use in patients with an ejection fraction (EF) of less than 25% has not been evaluated.
See the Instructions for Use before performing DIAMONDBACK 360® coronary orbital atherectomy procedures for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information call CSI at 1-877-274-0901 and/or consult CSI’s website at www.csi360.com.DIAMONDBACK 360® Peripheral Orbital Atherectomy SystemIndications: For use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae.Contraindications: The Systems are contraindicated for use in coronary arteries, bypass grafts, stents, or where thrombus or dissections are present.Adverse Events: Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm.Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

Our cutting-edge technology and educational courses help physicians understand the challenges that arterial calcium presents and how to intervene with Orbital Atherectomy in appropriate patients with the unified goal of helping improve patient outcomes.We collaborate with leading experts in the field to pioneer innovative solutions.

Commitment to Clinical & Economic Rigor

Physicians and payers are increasingly seeking clinical and economic evidence to allow them to make decisions regarding optimal treatment of patients. We are focused on conducting and collecting clinical and economic evidence to demonstrate the advantages of OAS in treating complex disease states such as PAD and CAD.

We believe that the clinical data and cost-effectiveness of our OAS technology will help drive physician utilization of the OAS and sustain ongoing reimbursement coverage for our devices.11

See the Devices in Action

How it works:

The unique mechanism of action (MOA) uses a combination of centrifugal force and differential sanding to treat arterial calcium.The Diamondback 360® Orbital Atherectomy Systems are designed to treat 360° of the vessel as it sands away the calcium, while allowing for continuous flow of blood and saline during orbit.

In July 2018, Cardiovascular Systems, Inc. (CSI®) announced that OrbusNeich Medical Co. Ltd. signed an exclusive distribution agreement to sell its coronary and peripheral Orbital Atherectomy Systems outside the United States and Japan.

In November 2016, Cardiovascular Systems, Inc. (CSI®) announced that Medikit, Co., Ltd. signed an exclusive distribution agreement to sell its coronary and peripheral Orbital Atherectomy Systems in Japan.

Smart Solutions that advance treatment for complex patients

At CSI, weare a culture of innovation.
We observe carefully, listen closely and collaborate extensively,
seeking opportunities to help interventionalists do their jobs more easily and more effectively –
all with the goal of improving patient care.